Associate Director - GRACS, Global Submissions Publishing Job - India
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This position will be responsible for working directly with vendors selected for Regulatory Content Management (RCM) and Global Submissions Publishing (GSP) activities and the ongoing management of Global Regulatory Affairs and Clinical Safety (GRACS) external partner relationships with vendor based in Mumbai, India. The role will focus on the management of newly outsourced scope of work by working collaboratively with our selected external partners. Responsibilities will include onboarding of new partners, managing workload and driving process improvement.
This role will be responsible for managing local implementation of the multi-year sourcing contract to expand GRACS publishing capacity and is expected to leverage best practices and drive innovation in the GSP / RCM space. This role will work seamlessly with colleagues in GRACS External Operations to ensure the global program for sourcing is executed effectively.
Responsibilities will include project management and oversight of partnership deliverables and timeliness at the site level as well as management of supplier performance, issues, risks and opportunities. This role will engage and collaborate closely with MSD and external partner stakeholders to manage and continuously improve the publishing process to ensure that all global regulatory documents and assembled submissions are efficiently and effectively delivered on time and of high quality.
The incumbent will require a working knowledge of regulatory publishing, outsourcing, and supplier management with a strong track record of demonstrated leadership and capability to foster collaborative relationships.
Primary responsibilities include but are not limited to:
• Manage the relationship between GSP / RCM and the external partner(s) to effectively deliver on objectives.
• Provide publishing management and oversight for the distribution of workload and the timely completion of deliverables at the site level; collaborate with cross-functional stakeholders and facilitate local discussions.
• Manage, track and escalate issues actively and appropriately. Communicate and articulate vendor performance issues and due diligence outcomes to appropriate parties both internally and externally.
• Ensure Quality and Compliance by collaborating with compliance colleagues, participating in audit activities and conducting local oversight.
• Monitor and manage vendor performance by collaborating with internal teams and external parties to ensure delivery of sourced submission work through clearly defined objectives. Aggregate performance metrics and support root cause analysis. Provide regular feedback to GSP management, internal teams and external partners.
• Support innovation and opportunity management and drive continuous improvements. Actively collaborate with and provide guidance to vendors to assure new capabilities and services are developed and existing capabilities and processes are assessed and improved (on an ongoing basis), and assuring consistent application of roles and processes across projects.
• Work closely with HQ GRACS External Operations to implement multi-year sourcing strategy.
• Actively participate in and effectively prepare for Sourcing Governance committee interactions.
• Required: Bachelor’s degree
• Preferred: Advanced degree and/or MBA preferred
• Solid knowledge and experience in Regulatory Publishing
• Effective management and organizational skills to efficiently manage multiple publishing teams.
• Demonstrates deep understanding of the business value of timeliness, quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables
• Demonstrates the ability to independently solve complex problems that arise within job responsibilities and expectations and takes a new perspective using existing solutions
• Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and drive results
• Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures
• Minimum of 8 years experience within the healthcare/consumer care industry, regulatory affairs or pharmacovigilance function that includes working with external partners.
• Minimum of 6 years project management or oversight experience
• Knowledge of drug development, specifically regulatory, CMC, and global safety processes for pharmaceutical products, vaccines and/or biologic products.
• Strong interpersonal, communication and leadership skills.
• Ability to lead by influence and work effectively in matrix organizational structures.
• Demonstrated ability to build and maintain relationships with individuals across multiple locations.
• Direct experience supporting regulatory or CMC filings across a variety of submission types.
• Expertise with industry standard electronic document management system
• In depth working knowledge of Liquent InSight Publisher or other industry standard publishing systems
Job: Regulatory Affairs Generic Job Title:Assoc. Dir, Regulatory Affairs
Primary Location: APAC-IN-MH-Mumbai
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD
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